Full job description Date: May 9, 2024
Location: Mansfield, MA, US
Company: Teleflex
Expected Travel : Up to 10%
Requisition ID : 10312
About Teleflex Incorporated Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary This position is responsible for performing product inspections, implementing controls, standards, procedures and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes.
Principal Responsibilities With the direction of the Quality Engineer, this position assists with
Performing inspections and laboratory tests as assigned Addressing product quality issues and non-conformances Support process compliance and related documentation Daily production support Participate in continuous improvement projects Specific responsibilities include:
Incoming, in-process, and final inspections Material testing, analysis, and documentation of results Identification of non-compliances (product or process) via creation of nonconformances using (NC) process First article inspections and product/process validation activities Perform creation and inspection of product identification labels Support document control activities (Agile updates, work package validation & storage) Support creation and maintenance of calibration records/plans Perform Endotoxin testing, Color test and IV lab tests Support customer complaint investigation activities Perform Environmental testing including temperature monitoring Peform Device History Record review and product release activties in SAP Follow safety, manufacturing and QA procedures and requirements Education / Experience Requirements Minimum of a High School Diploma or equivalent required Minimum of 2 years' vocational training or Associates Degree in a technical field (such as industrial technology) OR a minimum of 3 years' experience working in and industrial environment Knowledge and experience of working in the medical device industry preferred ASQ Certification desired Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired Experience in Lean/Six Sigma techniques preferred Six Sigma Green Belt preferred Strong analytical & problem-solving experience (DMAIC, 5Ws, Cause-Effect methods preferred) Previous participation in 5S events & FMEAs preferred Minitab and SAP experience preferred Specialized Skills / Other Requirements Proficiency in reading and interpreting engineering drawings, specifications, dimensioning & tolerances, procedures and documentation. Proficiency in use and understanding of measurement & test equipment including an understanding of Gage R&R process. Excellent math, analytical and problem-solving skills. Proficient computer skills in Microsoft Office required. Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality. Must possess excellent communication skills, both verbal & written. Must be able to interface directly with employees & internal Teleflex suppliers. "Hands-on" approach towards manufacturing floor involvement. Ability to work in fast paced, team-oriented work environment. Knowledge of validation processes highly preferred. Ability to work as part of an effective team TRAVEL REQUIRED 0-10 %
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: or .
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
